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

The Alliance of Dedicated Cancer Centers (ADCC) is pleased to comment on the draft LCD DL39270 and related article for Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin.

ADCC members are the country’s preeminent academic medical centers that focus exclusively on cancer patients. Our institutions are committed to disseminating best practices for patient treatment and our centers are among the most experienced with allogeneic stem cell transplants.

Because of this, we taken an interest in developments concerning coverage of treatments for cancer and related conditions. ADCC is appreciative that Palmetto has initiated this LCD and billing and coding article, particularly since the Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §110.23 for Stem Cell Transplantation is silent on coverage for lymphoma. We recognize that silence allows individual Medicare Administrative Contractors (MACs) to make coverage determinations upon claim submission, but given the scientific advancements making allogeneic stem cell transplants for lymphoma more of the standard of care, we believe it is best to provide explicit coverage, rather than post-procedure coverage determinations as these can pose significant financial risk for both providers and patients. This draft LCD, once finalized, will help resolve this issue and expand Medicare beneficiary access. We urge Palmetto to finalize the proposed LCD as soon as possible.

Our comments are technical in nature and relate to the billing and coding article DA59042 in support of this draft LCD.

Thank you for your comments. Palmetto GBA agrees that effective coverage policy can serve many functions including facilitation of beneficiary access to evidence-based quality medical care demonstrating positive health outcomes.

Thank you for providing an opportunity to comment on the draft LCD DL39270 and related article for Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin.

The Medical University of South Carolina Bone Marrow Transplant program performs the majority of the allogeneic hematopoietic stem cell transplantations (alloHSCT) in the state of South Carolina. Over fifty percent of our patient population have Medicare as their primary coverage.

It is very appropriate and necessary for Palmetto to issue this LCD and billing and coding article. The CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §110.23 for Stem Cell Transplantation is silent concerning coverage for lymphoma and thus it is a significant financial risk for both providers and patients to furnish the procedure without explicit assurance of Medicare coverage. In the past, our center has not proceeded with the transplantation of these patients because of the absence of a local coverage decision. Therefore, many patients who needed this life saving treatment have not had access to this therapy.

Specific examples of the need for allogeneic transplantation in lymphoma include, but are not limited to the following:

1. T-cell lymphomas: Allogeneic transplantation is the only curative therapy for a number of relapsed T-cell lymphoma patients. Outside of allogeneic transplantation, therapies are frequently palliative with low response rates and short durations of response. The need for allogeneic transplantation is highlighted by:

• This CIBMTR analysis specifically concluding that “We hope that the data from this study will provide the direct evidence needed to justify modification of the current Medicare national coverage determination to allow for allo-HCT in NHL.”

• • • Shah, N.N., et al., Outcomes of Medicare-age eligible NHL patients receiving RIC allogeneic transplantation: a CIBMTR analysis. Blood Adv, 2018. 2(8): p. 933-940.

• Allogeneic transplantation for multiple T-cell lymphomas a recommended by this set of guidelines by the ASBMT.

• • • Mohamed KD, et al., Clinical Practice Recommendations on Indication and Timing of Hematopoietic Cell Transplantation in Mature T Cell and NK/T Cell Lymphomas: An International Collaborative Effort on Behalf of the Guidelines Committee of the American Society for Blood and Marrow Transplantation. Biology of Blood and Marrow Transplantation, 2017

2. Research indicates that allogeneic stem cell transplantation is likely to become more common for NHL patients over the coming years, especially for diffuse large B-cell lymphoma and mantle cell lymphoma. Allogeneic transplants are needed as another option since many of the other available therapies, including chimeric antigen receptor T-cell (CAR T-cell) therapy, are not curing the majority of the patients after relapse. There seems to be a benefit of early utilization of allogeneic stem cell transplant even after CAR-T cell therapy.

                        i. https://ashpublications.org/bloodadvances/article/3/20/3062/422497/Safety-of-allogeneic-hematopoietic-cell-transplant

                       ii. https://tandem.confex.com/tandem/2022/meetingapp.cgi/Paper/19056

As Palmetto accurately states in the draft LCD “per the NCD, “All other indications for stem cell transplantation not otherwise noted above as covered or non-covered remain at local Medicare Administrative Contractor discretion.”

Via this LCD and associated article, Palmetto intends to describe additional covered indications for allogeneic stem cell for primary refractory or relapsed Hodgkin's and non-Hodgkin's lymphoma with B-cell or T-cell origin.

Specifically, the draft LCD addresses multiple forms lymphoma included in C81.xx, C82.xx, C83.xx, C84.xx, C85.xx, C86.xx, C88.xx ICD-10-CM coding ranges.

We note that the following ICD-10-CM codes for lymphoma were not listed and request that they be included in the final documents:

C91.5 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated)

C91.50 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated), not having achieved remission

C91.51 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated), in remission

C91.52 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated), in relapse

The billing and coding article states that a claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as incomplete. We note that it is important that the diagnoses are able to be reported in either the principal or any secondary position following coding guidelines. We ask that the article confirm that a valid diagnosis code can be reported in any position. Furthermore, the article notes that 8 additional ICD-10-CM diagnosis codes can be submitted in FLs 67A-67Q, but that this is only applicable for paper UB-04 claims and that up to 24 additional conditions beyond the principal diagnosis can be submitted with electronic claims in the 5010 format as required by CMS. We ask that the final article reference electronic claim submission and that Palmetto will include all reported ICD-10-CM diagnosis codes on both inpatient and outpatient claims when assessing ICD-10-CM codes for covered conditions.

We urge Palmetto to finalize the LCD and billing and coding article, with the requested revisions, as soon as possible.

Thank you for your comments. Palmetto GBA shares your perspective that allo-HCT may have significant potential benefit for Medicare beneficiaries with serious lymphomas. Caution is urged regarding statements suggesting that any A/B Medicare Administrative Contractor local coverage determination provides “explicit assurance of Medicare coverage.” A well-documented medical record that fully explains the beneficiary’s unique circumstances, precise diagnoses and therapeutic needs is the foundation that allows for evidence-based coverage of reasonable and necessary medical care.

Your request for inclusion of ICD-10 codes C91.50-C91.52 is noted. Inclusion of these codes in this billing and coding article is somewhat redundant as national coverage for allogeneic hematopoietic stem cell transplant is already in place for these diagnoses and has been in effect since August 1, 1978. (Medicare Claims Processing Manual, Pub. 100-04, Chapter 32, §90). However, for absolute clarity, these requested ICD-10 codes will be added to this article. Allogeneic-HCT in front-line consolidation is recommended for acute and lymphoma types of adult T cell lymphoma/leukemia (HTLV-1 associated) and is recommended for relapsed-sensitive disease adult T cell lymphoma/leukemia that is acute, lymphoma type or smoldering/chronic. (Kharfan-Dabaja MA, Kumar A, Ayala E, et al. Clinical Practice Recommendations on Indication and Timing of Hematopoietic Cell Transplantation in Mature T Cell and NK/T Cell Lymphomas: An International Collaborative Effort on Behalf of the Guidelines Committee of the American Society for Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2017;23(11):1826-1838. doi:10.1016/j.bbmt.2017.07.027)

Coding of diagnoses, regardless of position on a claim, must be accurate, complete and consistent with Official Guidelines for Coding and Reporting. Diagnosis codes that are relevant and underlie the actual need for allogeneic hematopoietic stem cell transplant will obviously be represented by the principal diagnosis and/or secondary codes on a claim and will be considered in the assessment of the validity and accuracy of any claim (along with the entirety of a submitted medical record if requested). In an effort to eliminate any undue confusion, the information related to specific positions on specific types of claims for ICD-10 codes will be removed.

The University of Kansas Cancer Center Blood and Marrow Transplant and Cell Therapy program strongly supports the proposed LCD. We agree the current lack of a Local Coverage Determination (LCD) to clearly define coverage for allogenic hematopoietic cell transplantation (HCT) in select patients with lymphoma has led to a lack of adequate access to this medically necessary standard of care treatment for Medicare beneficiaries, confusion of covered services amongst health care providers, and a disparity of well-defined coverage criteria between MAC jurisdictions which do provide an LCD on this subject.

Implementing an LCD for the Palmetto jurisdiction will improve access to allogeneic HCT for Medicare beneficiaries. Providers will have clear guidelines on coverage for lymphoma patients. Standardizing the Medicare criteria access to HCT for this population will provide consistency between neighboring MAC jurisdictions and should influence the implementation of a National Coverage Determination for the same.

There is an abundance of peer reviewed literature to support adoption of an LCD for this treatment in the Medicare population. Furthermore, the National Comprehensive Cancer Center (NCCN) Guidelines provide clear guidance for coverage of allogeneic stem cell transplant in a variety of lymphomas. A thorough literature review has proven that HCT is a medically necessary treatment option for lymphoma. Therefore, HCT meets the Social Security Act criteria for coverage of medically necessary treatments. The proposed LCD will provide clear guidelines on the coverage of HCT for lymphoma in Medicare beneficiaries. The University of Kansas Cancer Center strongly supports and recommends implementation of the proposed LCD.

Thank you for your comments. Palmetto GBA agrees that local coverage determinations, in the absence of superseding applicable national coverage policy, can help greatly toward overall clarity and consistency regarding complex health issues and access to reasonable and necessary care that is potentially curative.

As the Director of the Stem Cell Transplant and Cell Therapy program at Wake Forest Baptist Comprehensive Cancer Center, I am very appreciative of Palmetto GBA’s leadership in drafting the local coverage determination (LCD), DL39279, Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin’s and Non-Hodgkin’s Lymphoma with B-cell or T-cell Origin. My colleagues and I across the region who provide this care to patients support this LCD. As written, the LCD will have a positive impact on the health of Medicare beneficiaries living with certain types of lymphoma and afford them access to allogeneic hematopoietic cell transplantation (allo-HCT).

As you are aware, both the American Society of Hematology (ASH) and the American Society of Transplant and Cell Therapy (ASTCT) have strongly endorsed this LCD. I am deeply engaged with both societies and their government relations and advocacy teams. The clinical teams in ASTCT have been instrumental in developing and implementing clinical care guidelines for Hematopoietic Cell Transplantation and Immune Effector Cell Therapy referenced in this draft LCD.

This LCD will expand coverage for allogeneic stem cell transplant for Medicare beneficiaries with 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, and when it is deemed medically necessary. The scientific evidence referenced in the draft LCD demonstrates the effectiveness in general and the comparable success of the procedure regardless of age, providing the justification for this coverage decision. The Medicare National Coverage Determination (NCD) for Allogeneic Stem Cell Transplantation (110.23) does not specifically include lymphoma as a covered indication, leaving Medicare beneficiaries with lymphoma without nationally consistent access to this potentially curative treatment and creating a different standard of care under Medicare than what is afforded to patients with commercial insurance. For the subset of lymphoma patients who are in need of allo-HCT it is their only option for curative intent therapy, making this LCD critically important.

I strongly support this LCD and am grateful to Palmetto GBA for addressing this gap in coverage and allowing our patients to access this life-altering treatment.

Thank you for your comments. Many professional societies and experts in the stem cell transplant field provided invaluable clinical context and information regarding standard of care practice to support the development of this local coverage policy; Palmetto GBA is grateful for the provision of their expertise.

Thank you for providing an opportunity to comment on the draft LCD DL39270 and related article for Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin.

Our center furnishes allogeneic hematopoietic stem cell transplantation (alloHSCT) to Medicare patients. We perform approximately 60-80 allograft transplants per year to individuals throughout the state of North Carolina and northern South Carolina. Approximately 1-5 of these transplants are performed for young patients with a history of primary or relapsed/refractory lymphoma especially after failure of CD19.CAR T cell or autologous stem cell transplant therapy. This is particularly true for patients with ATLL or other forms of high grade T cell where current recommendations often suggest upfront allogeneic stem cell transplant or allogeneic stem cell transplant at first recurrence.

It is very appropriate and necessary for Palmetto to issue this LCD and billing and coding article. The CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §110.23 for Stem Cell Transplantation is silent concerning coverage for lymphoma and thus it is a significant financial risk for both providers and patients to furnish the procedure without explicit assurance of Medicare coverage.

As Palmetto accurately states in the draft LCD “per the NCD, “All other indications for stem cell transplantation not otherwise noted above as covered or non-covered remain at local Medicare Administrative Contractor discretion.”

Via this LCD and associated article, Palmetto intends to describe additional covered indications for allogeneic stem cell for primary refractory or relapsed Hodgkin's and non-Hodgkin's lymphoma with B-cell or T-cell origin.

Specifically, the draft LCD addresses multiple forms lymphoma included in C81.xx, C82.xx, C83.xx, C84.xx, C85.xx, C86.xx, C88.xx ICD-10-CM coding ranges.

We note that the following ICD-10-CM codes for lymphoma were not listed and request that they be included in the final documents:

C91.5 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated)

C91.50 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated), not having achieved remission

C91.51 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated), in remission

C91.52 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated), in relapse

The billing and coding article states that a claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as incomplete. We note that it is important that the diagnoses are able to be reported in either the principal or any secondary position following coding guidelines. We ask that the article confirm that a valid diagnosis code can be reported in any position. Furthermore, the article notes that 8 additional ICD-10-CM diagnosis codes can be submitted in FLs 67A-67Q, but that this is only applicable for paper UB-04 claims and that up to 24 additional conditions beyond the principal diagnosis can be submitted with electronic claims in the 5010 format as required by CMS. We ask that the final article reference electronic claim submission and that Palmetto will include all reported ICD-10-CM diagnosis codes on both inpatient and outpatient claims when assessing ICD-10-CM codes for covered conditions.

We urge Palmetto to finalize the LCD and billing and coding article, with the requested revisions, as soon as possible.

Thank you for your comments. Please see Response 2 as it addresses the same concerns raised by that commenter.

The American Society of Hematology (ASH) and the American Society for Transplantation and Cellular Therapy (ASTCT) are very appreciative of Palmetto GBA’s leadership in drafting the local coverage determination (LCD), DL39279, Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin. Our Societies support this LCD, as written, and believe it will have a positive impact on the health of Medicare beneficiaries living with certain types of lymphoma by providing access to allogeneic hematopoietic cell transplantation (allo-HCT).

ASH represents more than 18,000 clinicians and scientists worldwide who are committed to the study and treatment of blood and blood-related diseases. These disorders encompass malignant hematologic disorders such as leukemia, lymphoma, and multiple myeloma, as well as non-malignant conditions such as sickle cell anemia, thalassemia, bone marrow failure, venous thromboembolism, and hemophilia. In addition, hematologists are pioneers in demonstrating the potential of treating various hematologic diseases and continue to be innovators in the field of stem cell biology, regenerative medicine, transfusion medicine, and gene therapy.

The ASTCT is a professional membership association of more than 3,000 physicians, scientists and other health care professionals promoting blood and marrow transplantation and cellular therapy through research, education, scholarly publication, and clinical standards. The clinical teams in our society have been instrumental in developing and implementing clinical care standards and advancing cellular therapy science, including participation in trials that led to current FDA approvals for chimeric antigen receptor T-cell (CAR-T) therapy.

Our Societies understand that the LCD will expand coverage for allogeneic stem cell transplant for Medicare beneficiaries with primary refractory or relapsed Hodgkin and non-Hodgkin’s lymphomas with B-cell or T-cell origin, for whom there are no other curative intent options when it is deemed medically necessary. The scientific evidence referenced in the draft LCD is recognized by our Societies as demonstrating the effectiveness in general and the comparable success of the procedure regardless of age, providing the justification for this coverage decision. The Medicare National Coverage Determination (NCD) for Allogeneic Stem Cell Transplantation (110.23) does not specifically include lymphoma as a covered indication, leaving Medicare beneficiaries with lymphoma without nationally consistent access to this potentially curative treatment and creating a different standard of care under Medicare than what is afforded to patients with commercial insurance. For the subset of lymphoma patients who need it, allo-HCT is their only option for curative intent therapy, making this LCD critically important.

ASH and ASTCT strongly support this LCD and are grateful to Palmetto GBA for addressing this gap in coverage and allowing our patients to access this life-altering treatment.

Thank you for your comments. Many professional societies and experts in the stem cell transplant field provided invaluable clinical context and information regarding standard of care practice to support the development of this local coverage policy; Palmetto GBA is grateful for the provision of their expertise.

Thank you for providing an opportunity to comment on the draft LCD DL39270 and related article for Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin.

Throughout my 28 year career as a stem cell transplant physician, I have had to turn away many Medicare beneficiaries whose lives could have been saved by allogeneic stem cell transplantation. While there are a variety of new, non-transplant options for these patients, this does not apply to all patients with non-hodgkin lymphoma; particularly those with T-cell disease.

It is very appropriate and necessary for Palmetto to issue this LCD and billing and coding article. The CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §110.23 for Stem Cell Transplantation is silent concerning coverage for lymphoma and thus it is a significant financial risk for both providers and patients to furnish the procedure without explicit assurance of Medicare coverage.

As Palmetto accurately states in the draft LCD “per the NCD, “All other indications for stem cell transplantation not otherwise noted above as covered or non-covered remain at local Medicare Administrative Contractor discretion.”

Via this LCD and associated article, Palmetto intends to describe additional covered indications for allogeneic stem cell for primary refractory or relapsed Hodgkin's and non-Hodgkin's lymphoma with B-cell or T-cell origin.

Specifically, the draft LCD addresses multiple forms lymphoma included in C81.xx, C82.xx, C83.xx, C84.xx, C85.xx, C86.xx, C88.xx ICD-10-CM coding ranges.

We note that the following ICD-10-CM codes for lymphoma were not listed and request that they be included in the final documents:

C91.5 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated)

C91.50 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated), not having achieved remission

C91.51 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated), in remission

C91.52 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated), in relapse

The billing and coding article states that a claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as incomplete. We note that it is important that the diagnoses are able to be reported in either the principal or any secondary position following coding guidelines. We ask that the article confirm that a valid diagnosis code can be reported in any position. Furthermore, the article notes that 8 additional ICD-10-CM diagnosis codes can be submitted in FLs 67A-67Q, but that this is only applicable for paper UB-04 claims and that up to 24 additional conditions beyond the principal diagnosis can be submitted with electronic claims in the 5010 format as required by CMS. We ask that the final article reference electronic claim submission and that Palmetto will include all reported ICD-10-CM diagnosis codes on both inpatient and outpatient claims when assessing ICD-10-CM codes for covered conditions.

We urge Palmetto to finalize the LCD and billing and coding article, with the requested revisions, as soon as possible.

Thank you for your comments. Please see Response 2 as it addresses the same concerns raised by that commenter.

Thank you for providing an opportunity to comment on the draft LCD DL39270 and related article for Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin.

Our center furnishes allogeneic hematopoietic stem cell transplantation (alloHSCT) to Medicare patients. The center offers adult stem cell transplants and is one of only three adult programs in Georgia accredited by both the Foundation for the Accreditation of Cellular Therapy (FACT) for autologous and allogeneic transplants and cell processing and the National Marrow Donor Program (NMDP). The center has recently added CAR-T cell therapy for definitive treatment of certain blood cancers. Currently, on an average, we are doing 105 transplants and about 10 CAR-T cell therapies in a year. Our multidisciplinary transplant team consists of five full time attending physicians, six Advanced Practice Providers (APP), Nurses, Quality Coordinator, Finance Coordinator, Data Coordinator and other allied administrators.

It is very appropriate and necessary for Palmetto to issue this LCD and billing and coding article. The CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §110.23 for Stem Cell Transplantation is silent concerning coverage for lymphoma and thus it is a significant financial risk for both providers and patients to furnish the procedure without explicit assurance of Medicare coverage.

As Palmetto accurately states in the draft LCD “per the NCD, “All other indications for stem cell transplantation not otherwise noted above as covered or non-covered remain at local Medicare Administrative Contractor discretion.”

Via this LCD and associated article, Palmetto intends to describe additional covered indications for allogeneic stem cell for primary refractory or relapsed Hodgkin's and non-Hodgkin's lymphoma with B-cell or T-cell origin.

Thank you for your comments.

The following comment was received from multiple stakeholders:

Thank you for providing an opportunity to comment on the draft LCD DL39270 and related article for Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin’s and Non-Hodgkin’s Lymphoma with B-cell or T-cell Origin.

Our center furnishes allogeneic hematopoietic stem cell transplantation (alloHSCT) to Medicare patients, for patients with life-threatening blood cancers and other blood diseases.

It is appropriate and necessary for Palmetto to issue this LCD and billing and coding article. The CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2, §110.23 for Stem Cell Transplantation is silent concerning coverage for lymphoma and thus it is a significant financial risk for both providers and patients to furnish the procedure without explicit assurance of Medicare coverage. In the past, due to this lack of coverage, our center has been limited in our ability to treat patients with certain types of lymphoma cancer who could benefit from this life saving procedure.

As Palmetto accurately states in the draft LCD “per the NCD, “All other indications for stem cell transplantation not otherwise noted above as covered or non-covered remain at local Medicare Administrative Contractor discretion.”

Via this LCD and associated article, Palmetto intends to describe additional covered indications for allogeneic stem cell for primary refractory or relapsed Hodgkin’s and non-Hodgkin’s lymphoma with B-cell and T-cell origin.

Specifically, the draft LCD addresses multiple forms lymphoma included in C81.xx, C82.xx, C83.xx, C84.xx, C85.xx, C86.xx, C88.xx ICD-10-CM coding ranges.

We note that the following ICD-10-CM codes for lymphoma were not listed and request that they be included in the final documents:

C91.5 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated)

C91.50 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated), not having achieved remission

C91.51 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated), in remission

C91.52 for Adult T-Cell lymphoma/leukemia (HTLC-1 associated), in relapse

The billing and coding article states that a claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as incomplete. We note that it is important that the diagnoses are able to be reported in either the principal or any secondary position following coding guidelines. We ask that the article confirm that a valid diagnosis code can be reported in any position. Furthermore, the article notes that 8 additional ICD-10-CM diagnosis codes can be submitted in FLs 67A-67Q, but that this is only applicable for paper UB-04 claims and that up to 24 additional conditions beyond the principal diagnosis can be submitted with electronic claims in the 5010 format as required by CMS. We ask that the final article reference electronic claim submission and that Palmetto will include all reported ICD-10-CM diagnosis codes on both inpatient and outpatient claims when assessing ICD-10-CM codes for covered conditions.

We urge Palmetto to finalize the LCD and billing and coding article, with the requested revisions, as soon as possible.

Thank you for your comments. Please see Response 2 as it addresses the same concerns raised by that commenter.